Vitravir Film-Coated Tablets

VITRAVIR contains two active substances. Darunavir, a HIV - 1 protease inhibitor (PI) Ritonavir, a HIV - 1 and HIV - 2 protease inhibitor (PI) Each of these active substances, is also known as an antiretroviral medicine, works by inhibiting the proteases enzymes. VITRAVIR is used for the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of HIV medicines called protease inhibitors (PIs). VITRAVIR works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection. It is important that you see your healthcare professional regularly while you are taking VITRAVIR.

Do not take VITRAVIR: • If you previously suffered an allergic reaction to any of the active ingredients, darunavir or ritonavir, or any other ingredient of VITRAVIR (listed in section 6). • If you have liver problems • If you are taking medicines to treat tuberculosis (TB). • If you are pregnant or breastfeeding your baby.

Do not take VITRAVIR with any of the following medicines: • medicines to treat convulsions (epilepsy) (phenobarbitone or phenytoin) • medicines to treat allergy symptoms (astemizole) • medicines to treat tuberculosis (rifampicin, rifabutin) • medicines to treat high blood pressure as a result of problems with your lungs (sildenafil, bosentan) • medicines to treat gout if you have liver or kidney problems (colchicine) • medicines to treat prostate problems (alfuzosin) • medicines to treat migraine and headaches (dihydroergotamine, ergonovine, ergotamine, methylergonovine) • medicines to treat some stomach conditions (cisapride) • medicines to treat hepatitis C virus (boceprevir, telaprevir) • herbal products containing St John’s wort (usually used for depression) • medicines to treat high cholesterol (lovastatin and simvastatin) • medicines to treat psychiatric conditions such as schizophrenia (pimozide, blonanserin) • medicines to treat trouble with sleeping and/or anxiety (midazolam or triazolam) • medicines to treat fungal infections (ketoconazole, itraconazole, voriconazole) • medicines to treat narcotic dependence (buprenorphine/naloxone) • medicines to treat heart conditions (amiodarone, bepridil, flecainide, propafenone, quinidine, encainide, digoxin) • medicines to treat asthma or difficulty in breathing (salmeterol)

Do not share medicines prescribed for you with any other person. Always take VITRAVIR exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose of VITRAVIR is two tablets taken each day by mouth. The tablets must be taken with food. This is important to get the right levels of active substance in your body. A nutritional drink alone does not replace food. Do not change your dose of VITRAVIR without first talking to your doctor. See your doctor regularly while taking VITRAVIR.

• When your supply of VITRAVIR starts to run low, get more from your doctor or pharmacy. It is important not to run out of VITRAVIR. The amount of HIV in your blood may increase if the medicine is stopped for a short time. Your doctor will tell you how long your treatment with VITRAVIR will last. Do not stop treatment early.

If you have the impression that the effect of VITRAVIR is too strong or too weak, talk to the doctor or pharmacist. If you take more VITRAVIR than you should: In the event of overdosage, speak to a doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre for help. If you forget to take VITRAVIR: If you notice within 12 hours of the time you usually take VITRAVIR, you must take the tablets as soon as possible. Always take the tablets with a meal. Then take the next dose as usual. If you notice after 12 hours, then skip the dose and take the next dose as usual. Do not take a double dose to make up for a forgotten dose. Effects when treatment with VITRAVIR is stopped: Do not stop using VITRAVIR without talking to your doctor first. HIV therapy may increase your sense of well-being. Even if you feel better, do not stop taking VITRAVIR or your other HIV medicines. Doing so could increase the risk of the virus developing resistance. Talk to your doctor first.

VITRAVIR can have side effects. Not all side effects reported for VITRAVIR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VITRAVIR, please consult your health-care provider for advice.

If any of the following happens, stop taking VITRAVIR and tell your doctor immediately or go to the casualty department at your nearest hospital: • swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing. • rash or itching, • fainting, • yellowing of the skin or eyes. These are all very serious side effects. If you have them, you may have had a serious reaction to VITRAVIR. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: • symptoms of infection (such as fever, aches and pains, feeling tired, coughing or sneezing, nausea, vomiting or diarrhoea) or inflammation after the start of treatment (immune reconstitution inflammatory syndrome) • inflammation of the liver or pancreas (symptoms may include belly pain, nausea and vomiting) • diabetes (high blood sugar) These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following: Frequent side effects: • headache • vomiting, nausea (feeling sick) • diarrhoea, stomach pain, flatulence (gas) • rash • high cholesterol and other fats in the blood • high blood sugar • tingling in the fingers and toes • bad taste in the mouth • sore throat and cough • weight loss and lack of appetite • nutrition disorders • anxiety and trouble falling and/or staying asleep • confusion, feelings of sadness (depression) • abnormal vision and visual disturbances (problems with eyes and eyesight) • muscle and joint pain • kidney problems and difficulty with urination (passing water) • fever and pain • dilation of the blood vessels (veins get bigger)

Less frequent side effects: • changes in body fats (fat redistribution) • abdominal (belly) swelling, indigestion, flatulence (gas) • itching • muscle pain • loss of strength and energy, tiredness • increase in pancreatic enzymes (digest fats, starches and proteins) • seizure (convulsions) • dehydration (thirsty due to loss of body water) because of vomiting and diarrhoea sometimes resulting in fainting • fainting • chest pains and cardiac (heart) problems, difficulty breathing • menstrual bleeding (periods) with heavy flow (menorrhagia) • blood disorders (changes the results in some values of your blood tests) • dizziness • ear pain and hearing problems • impotence (decrease in sexual drive)

VITRAVIR may change some values of your blood chemistry. These can be seen in the results of blood tests. Your doctor will explain these to you. In some patients, VITRAVIR has been reported to cause a severe or life-threatening rash. In patients taking VITRAVIR and raltegravir, rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately. Contact your doctor if you develop a rash. Your doctor will advise you whether your symptoms can be managed on therapy or whether VITRAVIR should be stopped. VITRAVIR should not be taken if you suffer from liver problems. Some side effects are typical for anti-HIV medicines in the same family as VITRAVIR. These include: • raised blood sugar and worsening of diabetes. • muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been serious. • changes in body shape due to fat redistribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (buffalo hump). • joint aches and pains, joint stiffness or difficulty in movement. The cause and long-term health effects of these conditions are not known at this time. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store at or below 30 °C. Protect from light. Store in the original container. Do not remove from the carton until required for use. Keep the bottle tightly closed. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).